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โ† Trials
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The ORIGIN-FH Study

RecruitingNAAges 18 Years - anyAllUniversity of Wisconsin, Madison
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to identify different types of Familial Hypercholesterolemia (FH) in infants and newborns. Participants will: * undergo a cheek swab for genetic testing (parents only) * have 5 blood samples collected Participants can expect to be in the trial for 2 years.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria - parent participant: * Individuals in the expectant partnership providing informed consent are at least 18 years of age. * Ability to understand and willingness to sign a written informed consent document. * Willingness to comply with all study procedures and be available for the duration of the study. * Expectant parent (currently pregnant with fetus โ‰ฅ12 weeks gestation) where one or both partners have been diagnosed with possible or definite HoFH or HeFH based on Dutch Lipid Clinic Network (DLCN) or confirmed diagnosis from a healthcare provider. At minimum, at least one parent with HoFH or HeFH must be willing to consent to study participation. However, both parents will be invited to participate. * Parent(s) commit to using local laboratory services for infant blood samples, with mobile phlebotomy used as an alternative if available in their area. Inclusion Criteria - newborn participant: * Newborn does not have any congenital abnormalities or medical conditions that may interfere with collection of dried blood spot (DBS) specimen and newborn does not require admission to neonatal intensive care unit. Exclusion Criteria - parent and newborn participants: * Expectant partnership where neither partner meets diagnostic criteria for HeFH or HoFH. * Parent refuses consent for newborn's study participation. * Newborn has medical condition precluding DBS specimen collection, or a newborn's DBS specimen is not collected by 1 week of age. * Not suitable for study participation due to other reasons at the discretion of the investigators. * Parent and newborn live outside of the United States.
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What it tests

  • Screening for FH
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Where

1 site
University of Wisconsin - Madison
Madison, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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